BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8558439 · Received April 26, 2019

    Report

    Report Number
    9616656-2019-00395
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 10, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE BREAK OCCURRED WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 320119 BATCH NO. 8233893. IT WAS REPORTED THAT PEN NEEDLE BROKE OFF WHEN GOING TO INJECT. DID NOT BREAK OFF INTO SITE. VERBATIM: CONSUMER REPORTED THAT THE PEN NEEDLE BROKE OFF JUST BEFORE THE INJECTION AS SHE WAS TRYING TO INSERT THE NEEDLE INTO THE INJECTION SITE. THE NEEDLE DID NOT GO INTO THE SITE BUT BROKE OFF JUST BEFORE. NO MEDICAL ATTENTION NEEDED, NO INJURY. PROBLEM OCCURRED ABOUT 2 WEEKS AGO, CONSUMER DOES NOT RE-USE NEEDLE. LOT # 8233893, PRODUCT # 320119, EXP 08-31-2023. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348224 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8233893 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other